The purification processes for pharmaceutical grade monoclonal antibodies produced by fermentation culture typically involve four basic steps. These steps include (1) harvest/clarification—separation of host cells from the fermentation culture; (2) capture—separation of antibody from the majority of components in the clarified harvest; (3) fine purification—removal of residual host cell contaminants and aggregates; and (4) formulation—place the antibody into an appropriate carrier for maximum stability and shelf life.
However, often these steps do not necessarily address possible viral contamination. There is a present need for methods of producing and purifying an antibody of interest suitable for clinical use that includes reduction and/or inactivation of contaminating harmful viruses. The present invention addresses this need.